20. Sabapathy S, Kingsley RA, Schneider DA, Adams L, Morris NR. Continuous and intermittent exercise responses in individuals with chronic obstructive pulmonary disease. Thorax. 2004;59:1026-31. [PMID: 15563700] 21. Kaelin ME, Barnard K, Swank A, Adams K, Ponto A. Results <strong>of</strong> 6 minute ambulation and MET tolerance <strong>of</strong> patients with severe chronic obstructive pulmonary disease (COPD) utilizing 2 different aerobic training regimes: interval training versus continuous training. Presented at the American Society <strong>of</strong> Exercise Physiologists 2nd Annual Meeting, Indianapolis, Indiana, 1999. 22. Puhan MA, Schünemann HJ, Frey M, Scharplatz M, Bachmann LM. How should COPD patients exercise during respiratory rehabilitation? Comparison <strong>of</strong> exercise modalities and intensities to treat skeletal muscle dysfunction. Thorax. 2005;60:367-75. [PMID: 15860711] 23. Puhan MA, Büsching G, VanOort E, Zaugg C, Schünemann HJ, Frey M. Interval exercise versus continuous exercise in patients with moderate to severe chronic obstructive pulmonary disease—study protocol for a randomised controlled trial [ISRCTN11611768]. BMC Pulm Med. 2004;4:5. [PMID: 15310394] 24. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, CONSORT group. Reporting <strong>of</strong> noninferiority and equivalence randomized trials: an extension <strong>of</strong> the CONSORT statement. JAMA. 2006;295:1152-60. [PMID: 16522836] 25. Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975;31:103-15. [PMID: 1100130] 26. Borg GA. Psychophysical bases <strong>of</strong> perceived exertion. Med Sci Sports Exerc. 1982;14:377-81. [PMID: 7154893] 27. Meyer K, Samek L, Schwaibold M, Westbrook S, Hajric R, Beneke R, et al. Interval training in patients with severe chronic heart failure: analysis and recommendations for exercise procedures. Med Sci Sports Exerc. 1997;29:306-12. [PMID: 9139168] 28. Meyer K, Samek L, Schwaibold M, Westbrook S, Hajric R, Lehmann M, et al. Physical responses to different modes <strong>of</strong> interval exercise in patients with chronic heart failure—application to exercise training. Eur Heart J. 1996;17: 1040-7. [PMID: 8809522] 29. Puhan MA, Behnke M, Laschke M, Lichtenschopf A, Brändli O, Guyatt GH, et al. Self-administration and standardisation <strong>of</strong> the chronic respiratory questionnaire: a randomised trial in three German-speaking countries. Respir Med. 2004;98:342-50. [PMID: 15072175] 30. Puhan MA, Behnke M, Frey M, Grueter T, Brandli O, Lichtenschopf A, et al. Self-administration and interviewer-administration <strong>of</strong> the German Chronic Respiratory Questionnaire: instrument development and assessment <strong>of</strong> validity and reliability in two randomised studies. Health Qual Life Outcomes. 2004;2:1. [PMID: 14713317] 31. Schünemann HJ, Goldstein R, Mador MJ, McKim D, Stahl E, Puhan M, Interval Exercise for Patients with Chronic Obstructive Pulmonary Disease Article et al. A randomised trial to evaluate the self-administered standardised chronic respiratory questionnaire. Eur Respir J. 2005;25:31-40. [PMID: 15640320] 32. Schünemann H. Is there an association between impaired pulmonary function and mortality in never smokers? [Letter] Thorax. 2004;59:81. [PMID: 14694258] 33. Hinz A, Schwarz R. [Anxiety and depression in the general population: normal values in the Hospital Anxiety and Depression Scale]. Psychother Psychosom Med Psychol. 2001;51:193-200. [PMID: 11417357] 34. Bennet K, Torrance GW. Measuring health state preferences and utilities: rating scale, time trade-<strong>of</strong>f, and standard gamble techniques. In: Spilker B, ed. Quality <strong>of</strong> Life and Pharmacoeconomics in Clinical Trials. 2nd ed. Philadelphia: Lippincott–Raven; 1996:253-66. 35. Schünemann HJ, Griffith L, Stubbing D, Goldstein R, Guyatt GH. A clinical trial to evaluate the measurement properties <strong>of</strong> 2 direct preference instruments administered with and without hypothetical marker states. Med Decis Making. 2003;23:140-9. [PMID: 12693876] 36. Puhan MA, Behnke M, Devereaux PJ, Montori VM, Braendli O, Frey M, et al. Measurement <strong>of</strong> agreement on health-related quality <strong>of</strong> life changes in response to respiratory rehabilitation by patients and physicians—a prospective study. Respir Med. 2004;98:1195-202. [PMID: 15588040] 37. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002;166:111-7. [PMID: 12091180] 38. Gøtzsche PC. Blinding during data analysis and writing <strong>of</strong> manuscripts. Control Clin Trials. 1996;17:285-90; discussion 290-3. [PMID: 8889343] 39. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance <strong>of</strong> rigorous methods. BMJ. 1996;313:36-9. [PMID: 8664772] 40. Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the Six Minute Walk test in chronic lung disease patients. Am J Respir Crit Care Med. 1997;155:1278-82. [PMID: 9105067] 41. Schünemann HJ, Griffith L, Jaeschke R, Goldstein R, Stubbing D, Guyatt GH. Evaluation <strong>of</strong> the minimal important difference for the feeling thermometer and the St. George’s Respiratory Questionnaire in patients with chronic airflow obstruction. J Clin Epidemiol. 2003;56:1170-6. [PMID: 14680667] 42. Fleming TR. Design and interpretation <strong>of</strong> equivalence trials. Am Heart J. 2000;139:S171-6. [PMID: 10740126] 43. Greene WL, Concato J, Feinstein AR. Claims <strong>of</strong> equivalence in medical research: are they supported by the evidence? Ann Intern Med. 2000;132:715-22. [PMID: 10787365] 44. McAlister FA, Sackett DL. Active-control equivalence trials and antihypertensive agents. Am J Med. 2001;111:553-8. [PMID: 11705432] 45. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value <strong>of</strong> clinical research for decision making in clinical and health policy. JAMA. 2003;290:1624-32. [PMID: 14506122] www.annals.org 5 December 2006 <strong>Annals</strong> <strong>of</strong> <strong>Internal</strong> <strong>Medicine</strong> Volume 145 Number 11 825
<strong>Annals</strong> <strong>of</strong> <strong>Internal</strong> <strong>Medicine</strong> Current Author Addresses: Dr. Puhan: <strong>Horten</strong> Centre, University Hospital <strong>of</strong> Zurich, Postfach Nord, CH-8091 Zurich, Switzerland. Mr. Büsching, Ms. vanOort, and Dr. Frey: Klinik Barmelweid, CH- 5017 Barmelweid, Switzerland. Dr. Schünemann: Department <strong>of</strong> Epidemiology, Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144 Roma, Italia. Dr. Zaugg: Kantonsspital Basel, Department <strong>of</strong> Research, ZLF 319, Hebelstrasse 20, CH-4031 Basel, Switzerland. Author Contributions: Conception and design: M.A. Puhan, G. Büsching, H.J. Schünemann, E. vanOort, M. Frey. Analysis and interpretation <strong>of</strong> the data: M.A. Puhan, H.J. Schünemann, M. Frey. Drafting <strong>of</strong> the article: M.A. Puhan, H.J. Schünemann. Critical revision <strong>of</strong> the article for important intellectual content: G. Büsching, H.J. Schünemann, E. vanOort, C. Zaugg, M. Frey. Final approval <strong>of</strong> the article: M.A. Puhan, G. Büsching, H.J. Schünemann, E. vanOort, M. Frey. Provision <strong>of</strong> study materials or patients: G. Büsching, E. vanOort, M. Frey. Statistical expertise: M.A. Puhan, H.J. Schünemann, C. Zaugg. Obtaining <strong>of</strong> funding: M.A. Puhan, M. Frey. Administrative, technical, or logistic support: M.A. Puhan, G. Büsching, E. vanOort, M. Frey. Collection and assembly <strong>of</strong> data: G. Büsching, E. vanOort, M. Frey. www.annals.org 5 December 2006 <strong>Annals</strong> <strong>of</strong> <strong>Internal</strong> <strong>Medicine</strong> Volume 145 Number 11 W-229
Change language